Surviving an FDA Inspection of Your Clinical Trial Site

The Investigational New Drug (IND) regulations went into effect in 1963. Ever since, the U.S. Food and Drug Administration (FDA) has conducted clinical site inspections under what is known as the Bioresearch Monitoring Program. The agency now conducts several hundred inspections of clinical investigators annually to obtain compliance with the regulations and to ensure that data submitted to the FDA are substantiated by appropriate records.

Phase III clinical research has the potential for eye-catching margins, but private practitioners who enter the, field with that motive seldom stay. The reason? Financial returns don't come easily, and the process is fraught with opportunities for failure.